Public Workshop - An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment - April 21, 2015

The Food and Drug Administration (FDA) announced a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment."

The purpose of the workshop was to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public actually uses the device.

Registration to Attend the Workshop:

Onsite registration will be available. For all registration questions please contact Susan Monahan at susan.monahan@fda.hhs.gov or 301-796-5661.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make a comment during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that comments focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.